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Nicolet Cortical Stimulator

1-10

Revised 8/27/13

Environmental considerations (operating)

Environmental considerations (non-operating)

Regulatory standards

The Nicolet Cortical Stimulator meets the following safety standards set by 
domestic and international regulatory agencies for Medical Electrical Equipment.

Type BF applied device.

Temperature

15.6°C to 32.2°C (60°F to 90°F)

Relative Humidity

20% - 80% (non-condensing)

Altitude

0-3 km (0-10,000 ft)

Temperature

17.7°C to 55°C (0°F to 132°F)

Relative Humidity

10% - 90% (non-condensing)

Altitude

0-12 km (0-40,000 ft)

UL 60601-1

Medical Electrical Safety Standard (USA)

CAN/CSA-C22.2 no. 
601.1-M90

Medical Electrical Safety Standard (Canada)

EN/IEC 60601-1

Medical Electrical Safety of Medical Equipment 
(International and Europe)

IEC 60601-2-26

Particular safety of electroencephalographs equipment

IEC 60601-2-40

Particular safety of electromyography and evoked response 
equipment

EN 60601-1-2

Collateral safety standard for EMC

CE Mark

Содержание Nicolet SCU

Страница 1: ...ne of its subsidiaries All rights reserved Natus is a registered trademark of Natus Medical Incorporated All product names appearing on this document are trademarks or registered trademarks owned lice...

Страница 2: ......

Страница 3: ...ce guides 1 4 Additional manuals available 1 4 Safety summary 1 5 Cautions and Warnings 1 6 Product specifications 1 7 System configuration disclaimers 1 8 a Antivirus and third party software and har...

Страница 4: ...mode Nicolet Panel PC 2 16 Performing a Cortical Stimulation Study Cortical Stimulator cabling diagrams 3 3 OR Probe Biphasic Mode 3 4 Electrode Mode Nicolet Desktop 3 5 Electrode Biphasic mode Nicol...

Страница 5: ...sing a hand held bipolar stimulator probe The Nicolet system records EEG signals directly from the cortex via intracranial electrodes By observing the patient in person or through reviewing of video a...

Страница 6: ...mark Compliant to Medical Device Directive 93 42 EEC Technical support Domestic International Natus Neurology Incorporated 3150 Pleasant View Road Middleton WI USA 53562 1 800 356 0007 madison helpdes...

Страница 7: ...t or operator at risk Image on blue background ISO 7010 M002 Consult Operating Instructions ISO 7000 1641 European Authorized Representative Manufacturer Natus Neurology Incorporated 3150 Pleasant Vie...

Страница 8: ...preserved This copy of the User Manual shall be used only in accordance with the conditions of sale of Natus Neurology Incorporated or its distributors Natus Neurology Incorporated makes no represent...

Страница 9: ...Revised 8 27 13 1 1 1 General Information...

Страница 10: ...Nicolet Cortical Stimulator 1 2 Revised 8 27 13 Blank Page...

Страница 11: ...ing stimulation via electrode pairs or a hand held bipolar probe C64 OR amplifier terminology The C64 OR Amplifier my be used when stimulus to the patient is delivered from the Stimulus Control Unit S...

Страница 12: ...pter 3 provides instructions on how to use the Cortical Stimulator equipment during a Cortical Stimulation Study Read the Safety Reference guides Please read the Additional Information and Safety Note...

Страница 13: ...practices that could result in damage to the equipment NOTE Notes help you identify areas of possible confusion and avoid potential problems during system operation IMPORTANT Read and follow all WARNI...

Страница 14: ...timulator product prior to initial use When in use the Nicolet Cortical Stimulator must be attended at all times by medical professionals trained in cortical stimulation The Nicolet Cortical Stimulato...

Страница 15: ...with a low current level and increase in small increments When stimulating with a hand held probe keep the probe in firm contact with cortical tissue Place the stimulator probe in contact with the neu...

Страница 16: ...software will interrupt the recording resulting in complete or partial inability to record patient data Natus Neurology Incorporated network consultants can recommend network and antivirus software co...

Страница 17: ...ons Length Width Height 3in 75mm 1in 25mm 4 5in 115mm 3in 76mm 1 7in 45mm System Power 15V 3A 45W Frequency Range 47 63Hz AC Voltage Current 100 240VAC 1 35A Current output Bi phasic constant current...

Страница 18: ...Humidity 20 80 non condensing Altitude 0 3 km 0 10 000 ft Temperature 17 7 C to 55 C 0 F to 132 F Relative Humidity 10 90 non condensing Altitude 0 12 km 0 40 000 ft UL 60601 1 Medical Electrical Saf...

Страница 19: ...ng the system Routinely check the components for exterior damage Periodically check the system ground integrity the system leakage current and the patient leakage current Follow your medical facilitie...

Страница 20: ...are around controls connectors and panel edges Do not use any abrasive cleaners The proper cleaning method for non critical medical devices permits the use of 70 isopropyl ethyl solution Remove any du...

Страница 21: ...Revised 8 27 13 2 1 2 Nicolet Cortical Stimulator Overview...

Страница 22: ...Nicolet Cortical Stimulator 2 2 Revised 8 27 13 Blank Page...

Страница 23: ...U D C64 OR Amplifier Headbox 1 2 R R N N 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 5...

Страница 24: ...ant current stimulation and may be connected to the Acquisition system via a Serial port on the Desktop Laptop or Panel PC computer The Stimulus Control Unit SCU can deliver the following stimuli Bi p...

Страница 25: ...from Medical Power Supply Nicolet Cortical Stimulator Status Setup Pulse Frequency Pulse Duration Electrode Electrode Train Duration Delivered Stim Set Stim Check Stim Ictal Disrupt Mark Channel Start...

Страница 26: ...the channel numbers H Set Stim 1 2 Sets the current level applied to the patient measured from baseline to peak 8 mAmps or less typical Enter the most significant value using the Selector Knob Press...

Страница 27: ...For service diagnostics and optionally for computer interface U Remote Start Stop Future use V Display Displays parameter options you can choose after pressing one of the parameter buttons W Isolated...

Страница 28: ...t the current level applied to the patient Display the stimulation level being applied Applies the selected stimulus to an internal load to verify correct operation The LED lights when this feature is...

Страница 29: ...Serial Date of Manufacture CE Mark Medical device listing mark for U S and Canada by Intertek Testing Service Special Recycling Required Do not dispose in landfill Electrostatic sensitive Attention co...

Страница 30: ...r acquires the electrical signals from the brain to the system for recording and display See C64 OR amplifier terminology in Chapter 1 for definitions of the C64 OR and C64 OR SSU amplifiers A C64 OR...

Страница 31: ...Control Unit SCU may be connected to a Nicolet system Desktop Laptop or Panel PC computer via an RS 232 port The stimulation delivered to the patient can be controlled from the Stimulus Control Unit S...

Страница 32: ...let Panel PC OR probe biphasic mode In this configuration the Stimulus Control Unit SCU is an independent device and does not require the Nicolet application EEG data is not collected in this configur...

Страница 33: ...C64 OR EEG amplifiers Cortical stimulation results along with EEG data are viewed on the Nicolet Acquisition Computer in the operating room which also acquires and stores the EEG data Note The Deskto...

Страница 34: ...ivered from the Stimulus Control Unit SCU to the Electrodes through the Stimulus Switching Unit SSU Electrode biphasic switching mode Nicolet desktop A Electrode Biphasic Switching Mode Nicolet Deskto...

Страница 35: ...trode Biphasic Switching Mode Nicolet Laptop B Electrodes C C64 Headbox D Stimulus Switching Unit SSU E Stimulus Control Unit SCU Medical Power Supply F Stimulus Control Unit SCU G Laptop Nicolet Acqu...

Страница 36: ...Panel PC A Electrode Biphasic Switching Mode Nicolet Panel PC B Electrodes C Headbox D Stimulus Switching Unit SSU E Stimulus Control Unit SCU Medical Power Supply F Stimulus Control Unit SCU G Panel...

Страница 37: ...Revised 8 27 13 3 1 3 Performing a Cortical Stimulation Study...

Страница 38: ...Nicolet Cortical Stimulator 3 2 Revised 8 27 13 Blank Page...

Страница 39: ...nnel operation Electrode Biphasic Stimulus Switching 1 2 R R N N 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 5...

Страница 40: ...n Electro de Electro de Train Duration Delivered Stim Se t Stim Ch eck Stim Ictal Disrup t Ch an ne l Mark Start Stop B A C 1 2 3 1 3 Cable Connections A Stimulator Probe Use only the Natus Neurology...

Страница 41: ...porated Bipolar Probe with 2 2 mm diameter tips E Desktop PC Red connector Black connector 1 2 R R N N 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37...

Страница 42: ...2 mm diameter tips E I Box F Hospital Grade Power Supply Provided G Laptop Computer Red connector Black connector 1 2 R R N N 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29...

Страница 43: ...u ratio n De livered Stim Se t Stim Ch eck Stim Ictal Disrup t Ch an ne l Mark Start Stop 1 2 R R N N 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37...

Страница 44: ...51 52 53 54 55 56 57 58 59 60 61 62 63 64 Ni colet Co r tic alStimula tor Statu s Se tup Pu lseFre qu en cy Pu lseDu rat ion Ele c tro de Ele c tro de Tra in Du rat ion De live red Stim Se tStim Ch ec...

Страница 45: ...SCU Side View A Stimulator Probe Use only the Natus Neurology Incorporated Bipolar Probe with 2 2 mm diameter tips B Stimulus Switching Unit SSU Interface C Remote Start Stop Future use D For service...

Страница 46: ...Nicolet Cortical Stimulator 3 10 Revised 8 27 13 Apply power to the Stimulus Control Unit SCU A B A Stimulus Control Unit SCU Bottom View B The green Power On LED illuminates when on...

Страница 47: ...sired option IMPORTANT The stimulus output is stopped automatically if the current delivered exceeds the requested current level by 20 or greater The Nicolet Cortical Stimulator must be turned off and...

Страница 48: ...b Rotate the Selector knob to choose Probe Bi phasic stimulus if using the probe or Electrode Bi phasic if using the Stimulus Switching Unit SSU Press the Selector knob to make your selection 4 Other...

Страница 49: ...he last selected Duration setting becomes the startup default setting 8 Positive Electrodes Press the Electrode Anode button and turn the Selector knob until the desired electrode number or label appe...

Страница 50: ...lation current level will reset to 0 mA Begin with the lowest current level and increase in small increments 11 Mark Channel If you want to mark the channels with ID tags prior to and after stimulatio...

Страница 51: ...ng Unit SSU 3 Train Duration Click on the Train Duration button and then select the desired train duration Units of seconds 5 seconds typical or Continuous if using a stimulator probe 4 Positive Elect...

Страница 52: ...tartup default setting 8 Stimulation level At startup the Stimulation level is set to 0 0 mA Click on the Set Stim show menu button and then select the desired stimulation level 0 15 mA 8 mA or less i...

Страница 53: ...n is displayed on the Stimulus Control Unit SCU display Level of stimulation being delivered to the patient is displayed If the level is 20 or more higher than the selected level stimulation is stoppe...

Страница 54: ...ol Unit SCU Stop button or stop from your Stimulus Control Unit SCU panel 2 To resume stimulating the patient press the Start button again Reviewing the recorded EEG Please refer to the Nicolet Inform...

Страница 55: ...Revised 8 27 13 4 1 4 Electromagnetic Compatibility EMC...

Страница 56: ...Nicolet Cortical Stimulator 4 2 Revised 8 27 13 Blank Page...

Страница 57: ...l Unit to Computer Use of cables or accessories other than those specified with the exception of cables and accessories sold by the manufacturer Natus Neurology Incorporated as replacement parts for i...

Страница 58: ...s acceptable for the Nicolet Cortical Stimulator to detect an error during EFT and ESD immunity testing as long as the user can recover by repowering the Nicolet Cortical Stimulator and or restarting...

Страница 59: ...hat of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical...

Страница 60: ...d separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interf...

Страница 61: ...as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 k...

Страница 62: ...Nicolet Cortical Stimulator 4 8 Revised 8 27 13 Blank page...

Страница 63: ...Revised 8 27 13 5 1 5 Error Codes...

Страница 64: ...Nicolet Cortical Stimulator 5 2 Revised 8 27 13 Blank Page...

Страница 65: ...One or more of the Stimulus Switching Units SSUs are not available ready Error 26 Decoder s communication error Error 27 A decoder disconnect occurred Error 28 Stimulus current flowing when it shouldn...

Страница 66: ...Nicolet Cortical Stimulator 5 4 Revised 8 27 13 Blank page...

Страница 67: ...etOne Laptop 3 8 Connections Probe Mode NicoletOne Desktop 3 7 Constant current 2 4 Copyright iv Cortical Stimulator cabling diagrams 3 3 Cortical Stimulator components 2 3 Cortical Stimulator paramet...

Страница 68: ...tor Knob 2 6 Serial Interface 2 6 Set Stim 2 6 3 14 Set the Cortical Stimulator parameters 3 11 3 15 Setup 2 6 Single Pulse 2 6 SSU Stimulus Switching Unit 1 3 1 4 2 14 2 15 2 16 Start 2 6 Start the s...

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